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Tundra Gifts: Harvesting Local And Regional Resources To Prevent Obesity Among Alaska Native Children In Remote, Underserved Communities

Primary Purpose

Childhood Obesity

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Tundra Gifts
Sponsored by
University of Alaska Fairbanks
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Childhood Obesity focused on measuring Healthy Eating, Alaska Native, Traditional Foods

Eligibility Criteria

3 Years - 5 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 3-5 year old children enrolled in Head Start and their primary caregiver in Yup'ik Alaska Native communities

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Tundra gifts program

    Comparison

    Arm Description

    Outcomes

    Primary Outcome Measures

    Change in age- and sex-specific BMI percentiles and z-scores
    Change in child intake of vegetables and fruit
    24-hour recall in combination with a 2-day food record
    Change in child intake of vegetables and fruit
    Skin carotenoid meter using reflection spectroscopy (veggie-meter)
    Change in child intake of sugar sweetened beverages
    Hair biomarker of sugar using N and C stable isotope ratios
    Change in child intake of sugar sweetened beverages
    24-hour recall in combination with a 2-day food record
    Change in child screen time
    Screen time questionnaire
    Change in child physical activity
    Physical activity questionnaire

    Secondary Outcome Measures

    Change in adult attitudes and beliefs around healthy eating and active lifestyle
    Attitudes and beliefs questionnaire
    Change in adult BMI
    Change in adult intake of vegetables and fruit
    skin carotenoid meter using reflection spectroscopy (veggie-meter)

    Full Information

    First Posted
    June 2, 2019
    Last Updated
    June 12, 2019
    Sponsor
    University of Alaska Fairbanks
    Collaborators
    Pacific Institute for Research and Evaluation, University of Alaska Anchorage, State of Alaska Department of Health and Social Services, Grand Valley State University, Alaska Native Tribal Health Consortium
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03986632
    Brief Title
    Tundra Gifts: Harvesting Local And Regional Resources To Prevent Obesity Among Alaska Native Children In Remote, Underserved Communities
    Official Title
    Tundra Gifts: Harvesting Local And Regional Resources To Prevent Obesity Among Alaska Native Children In Remote, Underserved Communities
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 1, 2019 (Anticipated)
    Primary Completion Date
    May 30, 2022 (Anticipated)
    Study Completion Date
    May 30, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Alaska Fairbanks
    Collaborators
    Pacific Institute for Research and Evaluation, University of Alaska Anchorage, State of Alaska Department of Health and Social Services, Grand Valley State University, Alaska Native Tribal Health Consortium

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The long-term goal of this community based participatory research project is to prevent obesity in 3-5 year old Alaska Native children in remote communities. Investigators will design and evaluate a culturally responsive, home-focused intervention, Tundra Gifts, that links early childhood education programming (i.e. Head Start) and federal food assistance programs (i.e. WIC and SNAP) with primary caregivers to support healthy eating and an active lifestyle using a cluster-randomized design. The intervention integrates behavior change theory with Indigenous traditional knowledge. Primary caregivers will attend monthly interactive education session, receive a monthly gift basket that includes resources and supplies to support behavior change at home and receive ongoing social support through a Facebook site. Investigators will also evaluate key process indicators of Tundra Gifts to understand the impact on outcomes of variations in persons and settings and to enhance the generalizability of findings.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Childhood Obesity
    Keywords
    Healthy Eating, Alaska Native, Traditional Foods

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    500 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Tundra gifts program
    Arm Type
    Experimental
    Arm Title
    Comparison
    Arm Type
    No Intervention
    Intervention Type
    Behavioral
    Intervention Name(s)
    Tundra Gifts
    Intervention Description
    Tundra Gifts is a home-focused intervention delivered by community health workers (CHW) that focuses on promoting healthy eating and an active lifestyle among 3-5 year olds through family and community partnerships. Primary caregivers will attend monthly interactive education session, receive a monthly gift basket that includes resources and supplies to support behavior change at home and receive ongoing social support through a Facebook site.
    Primary Outcome Measure Information:
    Title
    Change in age- and sex-specific BMI percentiles and z-scores
    Time Frame
    twice annually for 3 years
    Title
    Change in child intake of vegetables and fruit
    Description
    24-hour recall in combination with a 2-day food record
    Time Frame
    twice annually for 3 years
    Title
    Change in child intake of vegetables and fruit
    Description
    Skin carotenoid meter using reflection spectroscopy (veggie-meter)
    Time Frame
    twice annually for 3 years
    Title
    Change in child intake of sugar sweetened beverages
    Description
    Hair biomarker of sugar using N and C stable isotope ratios
    Time Frame
    twice annually for 3 years
    Title
    Change in child intake of sugar sweetened beverages
    Description
    24-hour recall in combination with a 2-day food record
    Time Frame
    twice annually for 3 years
    Title
    Change in child screen time
    Description
    Screen time questionnaire
    Time Frame
    twice annually for 3 years
    Title
    Change in child physical activity
    Description
    Physical activity questionnaire
    Time Frame
    twice annually for 3 years
    Secondary Outcome Measure Information:
    Title
    Change in adult attitudes and beliefs around healthy eating and active lifestyle
    Description
    Attitudes and beliefs questionnaire
    Time Frame
    twice annually for 3 years
    Title
    Change in adult BMI
    Time Frame
    twice annually for 3 years
    Title
    Change in adult intake of vegetables and fruit
    Description
    skin carotenoid meter using reflection spectroscopy (veggie-meter)
    Time Frame
    twice annually for 3 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    3 Years
    Maximum Age & Unit of Time
    5 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 3-5 year old children enrolled in Head Start and their primary caregiver in Yup'ik Alaska Native communities
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Andrea Bersamin, PhD
    Phone
    (907)474-6129
    Email
    abersamin@alaska.edu

    12. IPD Sharing Statement

    Learn more about this trial

    Tundra Gifts: Harvesting Local And Regional Resources To Prevent Obesity Among Alaska Native Children In Remote, Underserved Communities

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